Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Stoma closure 2-3 weeks after rectal surgery.

Stoma closure 16-24 weeks after rectal surgery.

Stoma closure

David Abelló

The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).

Total mesorectal excision (TME) is considered the gold standard in obtaining a negative circumferential resection margin for cancers of the middle and lower third of the rectum. Despite all the oncological benefits,TME in ultra-low anterior resection carries some important drawbacks, such as a longer operative time, and its association with a higher rate of anastomotic leakage which increases in the most distal anastomoses.

Among the measures adopted to reduce mortality, the creation of protective ostomies has proven to be effective, however the protective ileostomy and its closure are not free of complications, such as dehydration and chronic kidney failure. In the investigator's country, various studies have analyzed this time to closure, being 10.8 months on average and with an increase in morbidity when closure is delayed the longest.

There are few prospective studies on the timing of stoma closure, which mainly focused on morbidity and mortality related to early closure. These studies did not demonstrate any significant negative effects on morbidity or mortality. The reason for early closure of the stoma is to reduce complications related to it. Although its true incidence is unknown, most patients have some type of stoma-related complication, which can be avoided or decreased in the case of early closure. In addition to the complications on the patient and their quality of life, the hospital costs secondary to them are not negligible.

The TIMES study ("TIMing Evaluation of Stoma closure") arises from the need to know the ideal moment for the closure of derivative stomata after rectal surgery.

Therefore, the hypothesis is that patients who undergo early ileostomy closure (at 2-3 weeks) after ultra-low anterior resection have fewer complications than patients with late ileostomy closure (4-6 months).

The main objective of this study is to analyze the morbidity and mortality associated with both early (early group, CASES group) and late closure (late group, CONTROL group) of the derivative ileosomy.

In this study, patients scheduled for temporary stoma closure after scheduled colorectal surgery will be randomized into two groups: early closure (14-21 days after surgery) or late closure (4th-6th month after surgery).

Patients will be followed from the time of study entry until 12 months after stoma closure.

Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.

The LARS score has been validated and translated into several languages. By applying binomial regression on patient responses, the five issues that most bothered the patients were selected: incontinence for flatus, incontinence for liquid stool, frequency, clustering and urgency. Rating scale ranges from 0 to 42 points, and patients are classified into three groups: "no LARS" (0-20 points), "minor LARS" (21-29 points) and "major LARS" (30-42 points). According to the authors, the LARS score facilitates a fast identification of patients categorized as major LARS who will require treatment

The SF36 is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). There is a further unscaled single item on changes in respondents' health over the past year. For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).

Hospital Universitario La Fe

General Surgery and Digestive System Service. Coloproctology Unit. Hospital Universitario y Politécnico La Fe. Principal Investigator, Associate Professor of Surgery. University of Valencia.

Symptoms and General Pathology

Hernia

Incisional Hernia

Pathological Conditions, Anatomical

Postoperative Complications

Pharmaceutical Solutions

All Drugs and Chemicals

Abdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure

Abdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1.

The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture.

The skin will be closed using a subcutaneous purse-string closure

At the end of the follow up (12 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the abdominal wall seen on the abdominal CT scan with the patient at rest.

The radiologist is blinded to the patient's history and the technique used for fascial closure.

Control CT

The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.

Clinical Follow Up

Reinforcement with Light Polypropylene Mesh

The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer

The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and 12 months after surgery and by abdominal CT scan one year after stoma closure.

Secondary aims are to evaluate the tolerability and safety of the prothesis; complications, quality of life and the need for further treatments will be compared between the groups.

This is a multicentric study that will include patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer. Elective surgery for loop ileostomy closure with ASA\<4. Exclusion criteria include patients with allergy or intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with a life expectancy of \<12 months, chronic renal failure in haemodialysis and patients on steroid therapy.

Patients that agree to participate in the study will be randomized using an electronic formula (Excel) of a uniformly distributed variable assigning case/control randomly until the total number of patients are included.

In the control group, after the digestive tract is reconstructed, the closure of the abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins 4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in the study group will have the same procedure performed, and after the aponeurosis closure with PDS loop, an onlay light polypropilene mesh will be placed.

Each participant will have an assigned code depending on the participating Centre that will maintain anonymity at all times. All of the information will be registered in a database specifically designed for the study.

Statistical analysis will be performed by a descriptive study of the demographic variables and the incidence of incisional hernia after loop ileostomy closure. A comparative study between the groups will be performed using X2 test for categorical variables and t Student test or U-Mann for continuous variables. A binary logistic regression will also be performed to analyse the influence of each variable and to predict if the interventions produce incisional hernia.

Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure

Multicentric, Prospective, Randomized and Simple Blind Study to Determine the Efficacy of the Placement of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure in Patients With a Prior Rectal Resection for Cancer

The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 12 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).

Secondary endpoints are perioperative complications, including wound infection, hematoma, pain and reoperation.

The quality of life was evaluated by the SF-36 Quality of life test, during scheduled clinical visits over a period of 12 months.

Hospital Universitari Joan XXIII de Tarragona.

PhD Aleidis Caro

Herbal and Botanical

Cola

No irrigations trough the efferent limb of loop ileostomy

Butyrate irrigations trough the efferent limb of loop ileostomy

Saline irrigations trough the efferent limb of loop ileostomy

Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure

Irrigations trough the efferent limb of loop ileostomy

Low Anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer.

Ileostomy reversal performed in a second stage carries a high burden of postoperative complications.

Terminal ileum and colon dysfunction during bowel disconnection could negatively influence postoperative morbimortality after loop ileostomy reversal in Rectal Cancer patients.

Colonic microflora performs anaerobic breakdown of dietary fibre that reaches the gut in regular patients without ileostomy. One of the short-chain fatty acids (SCFAs) produced by bacteria is butyrate, the preferred substrate to be oxidized by colonocytes.

The effects of butyrate irrigations before ileostomy closure on colonic mucosa will be studied in 45 rectal cancer patients.

The effects of butyrate irrigation trough the efferent limb of loop ileostomy before its closure will be compared to the saline and non-irrigations group.

Short term outcomes, colonic microbiota composition and functional outcomes will be evaluated after ileostomy reversal.

1 treatment arm open label

1 treatment arm double-blind

1 treatment arm double-blind

Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)

Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients: Short-term Outcomes and Microbiota (BUTYCLO)

Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as:

Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.

Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.

Diversion colitis was graded as follows: Grade 0: Normal mucosa, Grade 1: Erythematous mucosa, Grade 2: Erythema and mucosa edema and Grade 3: Spontaneous bleeding or bleeding with the slightest contact with rectoscopy

Sequences of the variable portions of the 16s ribosomal RNA gene

This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health. Score from 0-100

Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores. Score from 0-27

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Ileostomy closure at a different time point

Ileostomy closure

Christoph A. Maurer, Prof.Dr.med.

The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.

In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.

Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study

Quality Of Life Survey using the GQLI - Questionnaire

Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter

Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.	NCT05284864	Rectal Cancer Total Mesorecta... Ileostomy - Sto... Ileostomy; Comp... Ileostomy Closu...	Stoma closure	18 Years -	Hospital Universitario La Fe
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure	NCT02896686	Incisional Hern...	Control CT Clinical Follow... Reinforcement w...	18 Years -	Hospital Universitari Joan XXIII de Tarragona.
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure	NCT02896686	Incisional Hern...	Control CT Clinical Follow... Reinforcement w...	18 Years -	Hospital Universitari Joan XXIII de Tarragona.
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)	NCT04795180	Rectal Cancer	Irrigations tro...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)	NCT04795180	Rectal Cancer	Irrigations tro...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME	NCT02609451	Rectal Cancer	Ileostomy closu...	18 Years -	Kantonsspital Liestal

Spots Global Cancer Trial Database for ileostomy closure