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Clipping versus Suturing the Stapleline during Sleeve Gastrectomy- a randomised controlled trial

Clipping versus Suturing the Stapleline during Sleeve Gastrectomy- a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036304
Enrollment
128
Registered
2025-03-17
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

E66.06

Interventions

Group 1: Suturing the stapleline during sleeve-gastrectomy Group 2: Clipping the stapleline during sleeve-gastrectomy

Sponsors

Universitätsklinikum Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • BMI = 35 with indication for sleeve gastrectomy • Sufficient knowledge of the German language to understand the Enlightenment and to be taken into account when making the decision • Capacity to consent • Follow-up care capability, so that it is possible to attend follow-up appointments after 14 days and 6 months postoperatively

Exclusion criteria

Exclusion criteria: • Previous operations in the upper GI tract • Serious previous illnesses (e.g. kidney failure) • Pregnancy or breastfeeding • Lack of consent • Inability to attend follow-up appointments • Lack of command of the German language • Contraindications to either reinforcement method

Design outcomes

Primary

MeasureTime frame
Bleeding events events requiring intervention after Sleeve Gastrectomy during the hospital stay (i.e. within 72 hours postoperatively)

Secondary

MeasureTime frame
Difficulty swallowing, hospital lemght of stay, postoperative drinking quantity, intraoperative fluid, operation time, patient satisfaction (Observation period 3 months)

Countries

Germany

Contacts

Public ContactMirko Otto

Universitätsklinikum Mannheim

mirko.otto@umm.de+49 621 383-2225

Outcome results

None listed

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