Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.

High-Dose radiotherapy

Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Chemo-radiotherapy

Philippe Rouanet, Pr

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Institut du Cancer de Montpellier - Val d'Aurelle

Pr Philippe Rouanet

Behaviors and Mental Disorders

Quality of Life

Temporary ileostomy with anal sphincter preservation

Permanent colostomy with total anal sphincter sacrifice

After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.

Abdominoperineal resection

After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy

Sphincter preservation surgery

Sung-Bum Kang, Ph. D.

Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.

This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.

Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial

Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Oncologic outcomes (recurrence, survival)

Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).

Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).

Seoul National University Bundang Hospital

National Cancer Center, Korea

Seoul National University Boramae Hospital

Hallym University Medical Center

Daehang Hospital

Seoul National University Hospital

Director of Colorectal Cancer Center, Principal Investigator, Professor

Symptoms and General Pathology

Anastomotic Leak

Gastrointestinal Agents

Laxatives

Cathartics

bowel preparation

no preparation bowel

PANIS Yves, Pr

The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma	NCT00979680	Rectal Cancer	High-Dose radio... Chemo-radiother...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma	NCT00979680	Rectal Cancer	High-Dose radio... Chemo-radiother...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial	NCT01461525	Rectal Cancer	Abdominoperinea... Sphincter prese...	20 Years - 80 Years	Seoul National University Hospital
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial	NCT01461525	Rectal Cancer	Abdominoperinea... Sphincter prese...	20 Years - 80 Years	Seoul National University Hospital
Rectal Cancer Surgery Without Mechanical Bowel Preparation	NCT00554892	Patients With R...	bowel preparati... no preparation ...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for sphincter preservation