Immediate versus MOdified DElayed coloanal anastomosis after Total Mesorectal Excision: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202209500145137

Enrollment

Registered

2022-09-09

Start date

2022-06-05

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Digestive System

Interventions

Immediate Coloanal Anastomosis

Modified delayed coloanal anastomosis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Algeria

Contacts

Public ContactHani Bendib

Department of Oncologic Surgery. Debussy Clinic. Algiers1 University

hanibendib@gmail.com+213550742110

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026