Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209500145137 Date of Approval: 09/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Immediate versus MOdified DElayed coloanal anastomosis after Total Mesorectal Excision: A Randomized Controlled Trial
Official scientific title Immediate versus MOdified DElayed coloanal anastomosis after Total Mesorectal Excision: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Immediate coloanal anastomosis (ICA) represents the standard technique for re-establishing the digestive tract after coloproctectomy for mid- and lower-rectal cancer. This anastomosis is associated with significantly high morbidity, motivating most surgeons to perform a diverting ileostomy. Being not free of risks, this last one comes to add its own set of complications. By reducing postoperative morbidity on the one hand, and by avoiding the discomfort of ileostomy, on the other hand, delayed coloanal anastomosis (DCA) may be an interesting alternative. Recently, a new variant of the Baulieux technique has been described. Called Short stump High anastomosis Pull-through " SHiP " by its promoters, it seems to have a low morbidity rate. The objective of this study is to estimate the rate of fistulas after SHiP versus ICA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IMODE
Disease(s) or condition(s) being studied Cancer,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 05/06/2022
Actual trial start date 21/09/2022
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 25/09/2024
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 77
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Immediate Coloanal Anastomosis Not applicable After Total Mesorectum Excision, the digestive tract is restored by a hand-sewn coloanal anastomosis with protective loop ileostomy. the ileostomy will be closed 6 to 8 weeks later, after radiographic control of the anastomosis. 35 Active-Treatment of Control Group
Experimental Group Modified delayed coloanal anastomosis Not applicable After Total Mesorectum Excision, the digestive tract is restored by a modified delayed coloanal anastomosis "Short stump High anastomosis pull-through" without diverting ileostomy. Between the 6th and 10th postoperative day, the patient is taken back to the OR under locoregional anesthesia. The colonic stump is then sectioned and a high coloanal anastomosis is made by single stitches with Vicryl® 000, joining the entire colonic wall to the sphincter; on average 12 stitches will be necessary. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age ≥ 18 years - Histologically proven cancer of the mid or lower rectum (lower pole of the tumor located within 10 cm of the anal margin) eligible for R0 surgery. - Patients with or without resectable or non-resectable distant metastases. - ycT4 tumors invading the external sphincter or levator ani requiring Abdominoperineal resection. - Anal incontinence (Wexner score ≥ 6) - Altered mental status preventing adherence to the study. - Refusal. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/05/2022 Debussy Clinic Scientific Committee
Ethics Committee Address
Street address City Postal code Country
7-9 Av. Mustapha Sayed El Ouali, Alger Ctre 16000 Algiers 16000 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anastomotic fistula rate. The International Study Group of Rectal Cancer (ISREC) definition will be adopted: "any dehiscence of the coloanal anastomosis leading to communication between the intra- and extraluminal compartment. at 3 months of follow-up
Secondary Outcome - Operating time, defined as the number of minutes from incision to closure of the surgical wound. - Operating interval, defined as the number of days between the two interventions. - Time to closure of the ileostomy. - Duration of the postoperative ileus, defined as the number of days until transit is restored. - Length of hospital stay, defined as the number of days spent in hospital following surgery. - Rate of complete mesorectum according to Quirke's classification. - Rate of R0 surgery, defined as the number of specimens with negative resection margins. - Rate of postoperative morbidity, defined as the number of complications occurring within 90 days postoperatively according to the Clavien-Dindo classification. - Rate of postoperative mortality, defined as the number of disease-related deaths occurring within 90 days postoperatively. - Rate of anastomotic stenosis, defined as the number of stenoses requiring dilatation or resection. - Readmission rate, defined as the number of re-hospitalizations. - Functional results, LARS score, St Marks score assessed at 3 months. Oncological results, local recurrence rate, distant recurrence rate, 1-year overall survival rate, 1-year disease-free survival rate. At 3 and 12 months of follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debussy Clinic 7-9 Av. Mustapha Sayed El Ouali, Alger Ctre 16000 Algiers 16000 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hani Bendib Residence 520 logts, GDC Algiers 16208 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debussy Clinic 7-9 Av. Mustapha Sayed El Ouali, Alger Ctre 16000 Algiers 16000 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hani Bendib hanibendib@gmail.com +213550742110 520 lgts, Bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16208 Algeria Department of Oncologic Surgery. Debussy Clinic. Algiers1 University
Role Name Email Phone Street address
Public Enquiries Hani Bendib hanibendib@gmail.com +213550742110 520 logt, Bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16208 Algeria Department of Oncologic Surgery. Debussy Clinic. Algiers1 University
Role Name Email Phone Street address
Scientific Enquiries Hani Bendib hanibendib@gmail.com +213550742110 520 logt, Bt42 N5, GDC
City Postal code Country Position/Affiliation
Algiers 16208 Algeria Department of Oncologic Surgery. Debussy Clinic. Algiers1 University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information