Recruitment

Recruitment Status
Completed

Inclusion Criterias

Medium risk of anastomotic leakage
Surgical Indication for Laparoscopic Anterior Rectal Resection
Medium risk of anastomotic leakage
Surgical Indication for Laparoscopic Anterior Rectal Resection

Exclusion Criterias

Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
Lower risk of anastomotic leakage
Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
...
Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
Lower risk of anastomotic leakage
Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
Advanced neoplasia (T4)
High risk of anastomotic leakage

Summary

Conditions
Colo-rectal Anastomosis Dehiscence
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Inclusion Criterias

Medium risk of anastomotic leakage
Surgical Indication for Laparoscopic Anterior Rectal Resection
Medium risk of anastomotic leakage
Surgical Indication for Laparoscopic Anterior Rectal Resection

Exclusion Criterias

Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
Lower risk of anastomotic leakage
Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
...
Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
Lower risk of anastomotic leakage
Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
Advanced neoplasia (T4)
High risk of anastomotic leakage

Tracking Information

NCT #
NCT01861379
Collaborators
Not Provided
Investigators
Not Provided