Impact of prophylactic EndoVAC on the incidence of anastomotic insufficiency after deep anterior rectal resection without diverting ileostomy

Impact of prophylactic EndoVAC on the incidence of anastomotic insufficiency after deep anterior rectal resection without diverting ileostomy - REFORMER

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035265

Enrollment

Registered

2024-12-06

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C20

Interventions

Group 1: All study participants will receive an intraoperative EndoVAC device as part of their elective deep anterior rectal resection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Indication for elective, deep anterior rectal resection for malignant and benign diseases of the rectum - Minimally invasive or open surgical removal (resection) - ASA I-III - Verbal and written informed consent - Ability to understand the content and scope of the study and be able to implement it

Exclusion criteria

Exclusion criteria: - Rectal resection as a secondary procedure - Coloanal anastomosis - Participation in another study that affects the study outcome impaired - > ASA III

Design outcomes

Primary

Measure	Time frame
Evaluation of the technical feasibility and efficacy of prophylactic EndoVAC therapy after deep anterior rectal resection for the prevention of anastomotic insufficiency	—

Secondary

Measure	Time frame
- Intra-abdominal abscesses - Postoperative intervention rate (CT/ultrasound-guided punctures) - Reoperation rate - Comprehensive Complication Index within 3 months after the operation - Postoperative complications classified according to the Clavien-Dindo classification (incidence: intra-abdominal abscesses, ileus, abscesses, ileus, peritonitis, sepsis, wound infection, wound healing disorder, ileus, abdominal distension, anastomotic bleeding) - Mortality (within the hospital stay and up to 3 months postoperatively) - Length of stay in IMC/ITS - Length of hospital stay	—

Measure

Time frame

- Intra-abdominal abscesses - Postoperative intervention rate (CT/ultrasound-guided punctures) - Reoperation rate - Comprehensive Complication Index within 3 months after the operation - Postoperative complications classified according to the Clavien-Dindo classification (incidence: intra-abdominal abscesses, ileus, abscesses, ileus, peritonitis, sepsis, wound infection, wound healing disorder, ileus, abdominal distension, anastomotic bleeding) - Mortality (within the hospital stay and up to 3 months postoperatively) - Length of stay in IMC/ITS - Length of hospital stay

—

Countries

Germany

Contacts

Public ContactBenjamin Müssle

Klinik für Allgemein- und Viszeralchirurgie

benjamin-moritz.muessle@uniklinik-ulm.de+49 73150053500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026