Single-stapled Double Purse-string Technique for Colorectal Anastomosis

Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04223141

Enrollment

Registered

2020-01-10

Start date

2020-03-17

Completion date

2025-12-31

Last updated

2026-05-06

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

Conditions

Colo-rectal Cancer

Keywords

Robot

Brief summary

A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Detailed description

In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Interventions

PROCEDURESIA

As indicated by arm description

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

(all must be fulfilled): * Verified cancer of the sigmoid colon * Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis * Operation with curative intent

Exclusion criteria

* Not legally competent and/or \< 18 years old * Not able to comprehend information and/or give written consent

Design outcomes

Primary

Measure	Time frame	Description
Technical success	30 days	Successful construction of anastomosis by double purse-string technique
Complications	30 days	Surgical complications graded by Clavien-Dindo
Mortality	30 days	Postoperative death

Secondary

Measure	Time frame	Description
LOS	90 days	Length of stay - number of days from day of operation to discharge
Readmissions	30 days	Unplanned hospital admissions at least 24 hs after discharge
Operation time	30 days	Duration of operation from incision to last skin stitch
Blood loss	30 days	Estimated intraoperative blood loss in ml
Medical complications	30 days	Medical complications graded by Clavien-Dindo and MESS

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORHelene J Würtz, MD

Staff Surgeon

PRINCIPAL_INVESTIGATORFlemming H Dall, MD PhD

Consultant

STUDY_DIRECTORHans B Rahr, MD DMSc

Department Head

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026