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Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)

Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)

During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.

Side-to-End Anastomosis

During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.

Transverse Coloplasty

Markus Rentsch, MD

Sandro M Hasenhütl, MD

Andreas Hölscher, MD

Carolin Orlitsch, MD

Johann Spatz, MD

CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.

Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.

Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

There is no plan to make individual participant data available to third parties beyond the study team.

Between group differences in stool frequency at t = 6 months postoperative

* Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses);
* Wound infection

Quality of Life with focus on colorectally specialized questionnaires

Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial	NCT03074461	Rectal Cancer Rectal Neoplasm... Rectal Tumors Fecal Incontine...	Side-to-End Ana... Transverse Colo...	18 Years -	Ludwig-Maximilians - University of Munich
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial	NCT03074461	Rectal Cancer Rectal Neoplasm... Rectal Tumors Fecal Incontine...	Side-to-End Ana... Transverse Colo...	18 Years -	Ludwig-Maximilians - University of Munich

Spots Global Cancer Trial Database for coloplasty pouch