Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Oculocerebral Syndrome With Hypopigmentation

Patients who underwent Proctectomy through an open approach

Patients who underwent Proctectomy through a Laparoscopic approach

Patients who underwent Proctectomy through a Robotic approach

Proctectomy

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach was compared for both primary and secondary outcomes.

Safe Colorectal Surgery in the Elderly

Safe Surgery in the Elderly: A Review of Outcomes Following Robotic Proctectomy From the Nationwide Inpatient Sample, a Retrospective Cross Sectional Cohort Study. Cross-Sectional Study

Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication

Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider

Madigan Army Medical Center

Tripler Army Medical Center

General Surgery Chief Resident Surgeon

Symptoms and General Pathology

Heart and Blood Diseases

Ischemia

Colitis

Colitis, Ulcerative

Ulcer

Colitis, Ischemic

Gastroenteritis

Colonic Diseases

Inflammatory Bowel Diseases

Vascular Diseases

Patients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate).

Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal

Standard proctectomy to excise the distal third of the rectum and the anal canal

Standard abdominal approach for rectal excision

Perineal incision to reach the distal rectum

APPEAR Procedure

standard rectal excision which does not preserve the anal canal

Prof Norman S Williams, MS FRCS

Charles H Knowles, PhD FRCS

Khalid El-Gendy, MBBS MRCS

Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous rectal diseases. However, this has not always been the case and this development has been facilitated by the invention of circular stapling instruments, which allow the bowel to be reconnected to the anal sphincters, where it would almost be impossible to do so manually. Nevertheless, some patients still require a permanent ostomy, as even with stapling devices ultra low joins of the bowel and sphincter muscles cannot always be performed by a conventional surgery. Therefore, a variety of alternative techniques have been proposed to avoid a permanent ostomy, but these have not become widespread due to the technical difficulty in performing them, their failure to completely eradicate rectal disease, and the damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.

The ideal ultra low sphincter preserving operation should remove the rectal disease entirely, allow the small or large bowel to be safely joined to the anal sphincters under direct vision, and retain the sphincter mechanism in its entirety. We propose such a technique that we term the APPEAR procedure, which approaches the lower third of the rectum via an incision between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter integrity, and allows either a stapled or manual join of the bowel to the sphincter mechanism, under direct vision. This trial is being conducted as a pilot study, with the procedure only offered to patients for whom a conventional sphincter saving procedure was technically impossible, or contraindicated.

This study is recruiting patients with distal third rectal pathology, for whom a conventional sphincter saving procedure is contraindicated, or likely to be technically impossible.

Recruited patients will initially undergo trial dissection by conventional sphincter preserving surgical techniques, which if successful will result in patients entering study arm 1.

However, should this not be possible, a trial anterior perineal dissection will be attempted, with patients entered into study arm 2 if perineal dissection is adequate to allow full rectal excision, and preserve sphincter integrity.

If during a trial of anterior perineal dissection it is decided that sphincter preservation is not safe, or will not allow eradication of rectal disease, conventional proctectomy will be performed, with patients entering study arm 3.

Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease

Queen Mary University of London

Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

loop ileostomi

Mark Ellebæk, MD

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Death occurring during the first 90 postoperative days

Odense University Hospital

Doctor

Behaviors and Mental Disorders

Recurrence

Quality of Life

the intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29)

Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).

quality of life

Arnaud Alves, MD, PhD

Yassine Eid, MD

Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures.

Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019".

The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting.

The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended.

In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form.

However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study.

This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.

Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.

Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)

score used : LARS score (for men and women). 5 questions about the low anterior resection syndrom. Scale between 0 and 42 points. Better outcome is 0 and worse is 42.

Score used : EORTC - QLQ C-30 - European Organization for research and treatment of cancer Quality of Life Questionnaire Core 30 (for men and women). It is a scale to evaluate the generic quality of life after cancer. There are 30 questions : 28 questions with 4 possible answers from 1 to 4 and 2 questions to evaluate the physical state and global quality of life with answers between 1 and 7. For each answer, 1 is the worst outcome and 4 is the best except for the 2 last questions where 7 is the best outcome. Minimum (worst outcome) is 30 and best outcome is 126. The total is reported to a score of 100 points which is the best outcome.

score used : EORTC - QLQ CR 29 European Organization for research and treatment of cancer Quality of Life Questionnaire Colorecatl module 29 (for men and women). This score is used in patients undergoing treatment for colorectal cancer. There are 29 questions with 4 possible answers (between 1 and 4 points). Best outcome is 4 for each question. Worst outcome is 1 for each question. Minimum (worst outcome) is 29 and best outcome is 116. The total is reported to a score of 100 points which is the best outcome.

score used : Urinary Symptom Profile : USP (for women). This scale is used to evaluate urinary symptoms. 1 question to evaluate stress urinary incontinence (between 0 and 9 points). 9 points is the worts outcome. 7 questions to evaluate overactive bladder symtoms (between 0 points and 21). 21 points is the worst outcome. 3 questions to evaluate low stream symtoms (between 0 and 9 points). 9 points is the worst outcome.

Global score is between 0 and 39 points. 39 points is the worst outcome and 0 points the best outcome.

score used : International Prostate Score Symptom : IPSS (for men). There are 7 questions with 5 possible answers (between 0 (best outcome) and 5 (worst outcome)). And one additionnal question to evaluate quality of life due to urinary symptom with 7 possible answers from 0 (best outcome) to 6 (worst outcome). for the seven first questions : best outcome is 0 and worst outcome is 35. For the last question 0 is the best and 6 is the worst outcome).

score used : Female Sexual Functionnal index : FSFI (for women). 19 questions on sexual sequelae in this questionnaire. Worst outcome is 2 and best outcome is 95 points.

score used : International Index for Erectile Function 5 : IIEF 5 (for men). 5 questions for sexual quality of life in males. Each questions have 5 answers. 5 points is the best outcome for each question. Minimal score is 1 and best score (best outcome) is 25.

University Hospital, Caen

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.

Pelvic MRI and F MISO TEP

Guillaume Portier, PhD

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.

Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas

Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.

acceptation rate of the entire sequence by eligible patients

radiological changes while on chimiotherapy, to tumour regression, and prognosis

Centre National de la Recherche Scientifique, France

Institut National de la Santé Et de la Recherche Médicale, France

University Hospital, Toulouse

Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires

Pre- and post-operative consultation

Clinical exam. At one and six months after the 2nd intervention

Stomatherapy consultation

* QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention)
* Stoma-QoL before and after the 2nd intervention
* LARS score at 1, 3, 6 and 12 months after the 2nd intervention

Questionnaires

Pascale COULON

This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be given to each patient.

The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse.

Before the 1st intervention (proctectomy):

* Collect of clinical data and disease history
* Quality of life questionnaires (EORTC-QLQ-C30 and CR29)
* Evaluation of LARS score

After the 1st intervention (proctectomy, at month 1):

- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

Before the 2nd intervention (coloanal continuity reconstruction):

- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

After the 2nd intervention (at month 1, month 3, month 6 and one year):

* at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications
* Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score

Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")

Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention

Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention

Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire

Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction

Describe surgical complications linked to the coloanal continuity reconstruction

Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Santelys Association

Groupement Interrégional de Recherche Clinique et d'Innovation

Centre Oscar Lambret

Diseases and Abnormalities at or Before Birth

Adenomatous Polyposis Coli

Diverticulitis

Diverticulum

Diverticular Diseases

Polyps

Adenomatous Polyps

Adenoma

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Herbal and Botanical

All Drugs and Chemicals

Cola

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

colorectal and coloanal anastomotic staple line without reinforcement

Staple line without reinforcement

Anthony J Senagore, MD, MBA, MS

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential exists to utilize CBSG as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study

The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.

Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.

W.L.Gore & Associates

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement

Procedure/Surgery

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Patients were considered for the study if they were at least 18 years of age and scheduled to undergo one the following (with the anastomosis \< 10 cm from the anal verge): low anterior resection, proctectomy, proctocolectomy or a restorative anastomosis by means of Hartmann's reversal, coloanal anastomosis, or ileo-pouch-anal anastomosis.

Dr. Anthony Senagore

Device

Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak

Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.

Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses

"Significant" Post Operative Complications

Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.

Overall Study

Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum.

Biopsy

Pascale MARIANI, LDD

Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .

Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma

Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth

Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997

Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)

In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safe Colorectal Surgery in the Elderly	NCT03765411	Rectal Cancer	Proctectomy	70 Years -	Tripler Army Medical Center
Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum	NCT00534131	Rectal Neoplasm... Colitis, Ischem... Colitis, Ulcera...	Standard abdomi... APPEAR Procedur... Proctectomy	16 Years -	Queen Mary University of London
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer	NCT01865071	Rectal Cancer	loop ileostomi	18 Years -	Odense University Hospital
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer	NCT01865071	Rectal Cancer	loop ileostomi	18 Years -	Odense University Hospital
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.	NCT03459235	Rectal Cancer Surgery	quality of life	18 Years - 80 Years	University Hospital, Caen
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas	NCT01619696	Rectal Adenocar...	Pelvic MRI and ...	18 Years - 80 Years	University Hospital, Toulouse
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction	NCT03292289	Rectal Cancer	Pre- and post-o... Stomatherapy co... Questionnaires	18 Years - 70 Years	Centre Oscar Lambret
Safe Colorectal Surgery in the Elderly	NCT03765411	Rectal Cancer	Proctectomy	70 Years -	Tripler Army Medical Center
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses	NCT00663819	Rectal Cancer Ulcerative Coli... Familial Adenom... Diverticulitis	GORE SEAMGUARD®... Staple line wit...	18 Years -	W.L.Gore & Associates
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma	NCT02849158	Rectum Adenocar...	Biopsy	18 Years -	Institut Curie
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma	NCT02849158	Rectum Adenocar...	Biopsy	18 Years -	Institut Curie
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.	NCT03459235	Rectal Cancer Surgery	quality of life	18 Years - 80 Years	University Hospital, Caen
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction	NCT03292289	Rectal Cancer	Pre- and post-o... Stomatherapy co... Questionnaires	18 Years - 70 Years	Centre Oscar Lambret

Spots Global Cancer Trial Database for proctectomy

Every month we try and update this database with for proctectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for proctectomy

Every month we try and update this database with for proctectomy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for proctectomy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.