Neoplasms

Digestive System Diseases

All Conditions

Sigmoid Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Sigmoid Diseases

At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.

indocyanine green fluorescence imaging lymphatic tracing

Liang Kang, MD. and Phd.

he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).

A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined With Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer

odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

Compare total number of retrieved lymph nodes in both group

Compare number of positive lymph nodes in both group.

The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group

The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

This is for the early postoperative complication

mortality, which defined as the event observed within 30 days after surgery

Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin

Overall survival was defined as the time from surgery to death from any cause

Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis.

Sun Yat-sen University

Chief physician，Assistant to the dean

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

A high tie of the inferior mesenteric artery (IMA) should be attempted. The inferior mesenteric vein section at the Treitz angle should be performed. The lymphatic tissue that accompanies the inferior mesenteric vein should be added.

A high tie of the inferior mesenteric artery (IMA) should be attempted. Lymphadenectomy of the lymphatic tissue that accompanies the IMA will be performed. The inferior mesenteric vein section could be performed at the discretion of the surgeon.

Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)

Complete mesocolon excision

Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.

Conventional locoregional lymphadenectomy

A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.

Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.

The patient does not know the group to which it has been assigned.

Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)

Postoperative complications within 90 days after surgery (Clavien-Dindo classification).

To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.

To compare the duration of surgery measured in minutes between the two arms

To compare the surgical bleeding measured in ml between the two arms

To compare the incidence of surgical conversion to laparotomy between the two arms

To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire

To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires

To compare the total number of lymph nodes resected and the lymph node ratio (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.

To compare the tumor local recurrence rate between the two arms.

To compare the survival rate (deaths from cancer) between the two arms

Pere Planellas Giné

Principal investigator

Behaviors and Mental Disorders

Rectal Neoplasms

Quality of Life

All the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Spouses of the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Medical outcomes: 36-item short form health survey (SF-36)

The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

In addition, this tool has been validated in Turkish patients

Short Form - 36

The World Health Organization disability assessment schedule II (WHODAS-II)

The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). This questionnaire has been validated in Turkish patients.

WHODAS-II

cihangir Akyol

The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses. The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18. The QoL of patients and that of their spouses changed following surgery for colorectal cancer.

These changes were more significant among male patients' spouses.

There is no doubt that radical colorectal surgery improves the oncological outcomes of patients with cancer. However, the literature has clearly documented that social, physical, sexual, and psychological aspects of life, as well as religious worship, are severely impaired after this treatment. A significant portion of patients suffer from alterations in their quality of life (QoL), particularly after surgery on distal rectal tumors. Patients who require a stoma or who have low anterior resection syndrome may face difficulty adapting to their new anatomy, managing the stoma, defecating, and continuing normal activities in their sociocultural environment. Patients pay an immense price following both sphincter-saving and sphincter-sacrificing surgery. Moreover, these psychological and social difficulties, as well as sexual dysfunction, may affect patients' relationships with their spouses, who are generally the primary informal caregivers for patients with cancer. In addition to caring for their sick partners, the spouses also have to deal with their own anxiety, fatigue, and depression.The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses.

Groups

Patients and their spouses were grouped by the type of surgery they received:

abdominoperineal resection (APR), sphincter-saving resection with an anastomosis within 6 cm of the anal verge on rigid sigmoidoscopy (LAR), or anterior resection with anastomosis at or above 7 cm, including sigmoid colectomy (AR).

The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18.

Counseling Surgical details, possible complications, and temporary or permanent stoma formation were explained preoperatively by the surgeon, and ostomy education was given by the stomatherapist. Religious education and counseling were also performed. Patients had direct access to doctors, the stomatherapist, appliance suppliers, and a religious leader (Imam) at the hospital during the study period.

Interviews Patients and spouses were interviewed at the Department of Surgery of Ibni Sina Hospital.

The coauthors of the study were trained to administer the questionnaires in a standard fashion and practiced by using the questionnaires on healthy volunteers before the study began.

Patients and spouses were interviewed in a private room by a person of the same gender. The same interviewer was used in the preoperative and postoperative period for each patient and spouse, but the interviewer was not blinded to the type of surgery that the patient had undergone. Patients were first asked to complete a demographic questionnaire designed to determine their age, gender, marital status, educational level, income level, and preoperative employment. The SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire were administered together and consisted of a total of 92 items, which took approximately 35 to 45 minutes to complete. Both patients and spouses completed the SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire preoperatively and at postoperative months 15 to 18.

QoL of Colorectal Cancer Patients and Spouses

Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses

Medical outcomes: 36-item short form health survey (SF-36)

The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

The World Health Organization disability assessment schedule II (WHODAS-II)

The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).

Cihangir Akyol

Associate Proffessor

Symptoms and General Pathology

Diverticulitis

Diverticulum

Diverticular Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Sigmoid resection surgery for patients who suffer from sigmoid cancer

Sigmoid resection surgery for patients who suffer from symptomatic diverticulitis

The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.

Sigmoidectomy

Emilie DUCHALAIS-DASSONNEVILLE, PH

The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

Rectal resection surgery can lead to numerous complications in term of gastrointestinal results with onset of fecal incontinence or in contrast constipation, and in term of genitourinary results with occurrence of dysuria, erectile dysfunction, or vaginal dryness. The low anterior resection syndrome is defined by the occurrence after rectal resection, of gastrointestinal symptoms like fecal incontinence or stool evacuation difficulties, which affect quality of life, despite conservation of anal sphincter. This syndrome is now well known and used in many countries.

However, there is a lack of data concerning gastrointestinal functional results after sigmoid surgery whether it is for cancer or diverticulitis. Some studies highlighted symptoms persistence in many patients after sigmoidectomy. Lately, the LARS score was used after sigmoidectomy for cancer. This study reveals symptoms of low anterior resection syndrome for 41 % of patients. The correlation between rectal resection and sigmoidectomy could be explain by the resection of the upper part of rectum in case of sigmoidectomy.

The issue of genito-urinary disorders after sigmoidectomy are poorly researched. Previous studies demonstrate a higher risk of erectile disorders after pelvic surgery and especially for cancer.

Currently, there is a lack of data on functional results and quality of life for patients who are going into sigmoid surgery, whether for cancer or diverticulitis. The aim of this longitudinal study is to compare digestive functional outcome, genitourinary outcomes and quality of life in patients who undergo sigmoid resection for diverticulitis and cancer.

Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer

Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer

To measure incontinence troubles after low anterior resection. The score is from 0 to 42. The higher the score, the worst the incontinence.

A scale to classify the form of the stools in seven category which indicate constipation or diarrhea in function of the type.

Types 1 and 2 indicate constipation, types 3 and 4 are normal stools, type 5, 6 and 7 indicate diarrhea.

Quality of life related to gastrointestinal symptoms. Score from 0 to 144. The higher the score, the better the quality of life.

General quality of life score. Described with 8 scaled scores, which are : vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, social role functioning, mental health.

Each scale score is from 0 to 100. The higher the score the less disability.

Measure of sexual functioning in women. Score from 0 to 95. The higher the score, the better the sexual function.

Questionary for evaluating female lower urinary tract symptoms and impact on quality of life.

Score from 0 to 48. The higher the score, the worst the urinary continence.

Questionary to screen and manage symptoms of benign prostatic hyperplasia. Score from 0 to 35. The higher the score, the worst the urinary function.

Questionary about erection problems on patient's sex life. Score from 1 to 25. The higher the score, the better the sexual function.

Nantes University Hospital

Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.

Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction

Adjuvant image-guided radiotherapy

Mu-Hung Tsai, MD

Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the risk of recurrence. The radiotherapy plan must account for organ movement inside the body to ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid colon between different fractions of radiotherapy treatment (interfraction motion) and within the same fraction (intrafraction motion). This knowledge will help us determine the optimal margin to use in radiotherapy treatment planning.

Day-to-day positioning variations contribute to uncertainty in radiotherapy. The International Commission on Radiation Units and Measurements (ICRU) report 62 recommended a margin added to the clinical target volume (CTV) to produce the planning target volume (PTV). In ICRU report 83, this concept is further extended and refined to yield the internal target volume (ITV), which is defined as CTV plus a margin to account for uncertainty within the patient. Image-guided radiotherapy (IGRT) has been developed as a method to lower the margin required in PTV expansion. In current practice, IGRT methods mostly rely on bony anatomy alignment. Due to its nature, internal organ motion cannot be compensated by IGRT. Therefore, an ITV expansion is still required. The optimal ITV expansion margin depends on the magnitude of internal organ motion; the smallest margin that provides adequate coverage is preferred.

In this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during radiotherapy treatment, including movement between fractions (interfraction) and movement within the same fraction (intrafraction).

Sigmoid Colon Organ Motion in Radiotherapy

Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy

Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT

Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT

Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT

National Cheng-Kung University Hospital

Attending Physician

Anastomotic Leak

A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice with the addition of intraoperative imaging using fluorescence angiography with indocianyne green to assess colon and rectal tissue perfusion.

A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice.

The fluorescence angiography was performed after mobilization of the bowel, transection of the rectum, division of the rectal and colon mesentery and central vessels, before specimen extraction or resection and creation of the anastomosis. This site was selected by the surgeon using his or her best judgment and typical standard of care assessment. After this selection, the anesthesiologist administered a bolus of 1 to 2 ml indocianyne green intravenously. Perfusion of the colon was visualized and assessed via fluorescence angiography and the line of demarcation between perfused and nonperfused tissue was noted and compared with the initial planned transection point.

Fluorescence angiography with indocianyne green

This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.

The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined With Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer	NCT06396806	Sigmoid Cancer	indocyanine gre...	18 Years - 75 Years	Sun Yat-sen University
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)	NCT03083951	Colorectal Canc... Sigmoid Cancer	Complete mesoco... Conventional lo...	18 Years - 79 Years	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined With Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer	NCT06396806	Sigmoid Cancer	indocyanine gre...	18 Years - 75 Years	Sun Yat-sen University
QoL of Colorectal Cancer Patients and Spouses	NCT04744792	Quality of Life Stoma Ileostomy Stoma Colostomy Rectum Cancer Sigmoid Cancer	Short Form - 36 WHODAS-II	18 Years -	Ankara University
Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer	NCT04729283	Sigmoid Cancer Sigmoid Diverti...	Sigmoidectomy	18 Years - 99 Years	Nantes University Hospital
Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer	NCT04729283	Sigmoid Cancer Sigmoid Diverti...	Sigmoidectomy	18 Years - 99 Years	Nantes University Hospital
QoL of Colorectal Cancer Patients and Spouses	NCT04744792	Quality of Life Stoma Ileostomy Stoma Colostomy Rectum Cancer Sigmoid Cancer	Short Form - 36 WHODAS-II	18 Years -	Ankara University
Sigmoid Colon Organ Motion in Radiotherapy	NCT03259828	Sigmoid Cancer Sigmoid Colon C...	Adjuvant image-...	20 Years -	National Cheng-Kung University Hospital
A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)	NCT03390517	Rectal Cancer Sigmoid Cancer	Fluorescence an...	18 Years -	State Scientific Centre of Coloproctology, Russian Federation

Spots Global Cancer Trial Database for sigmoid cancer