Remote Ischemic Preconditioning (RIPC) versus sham-control for reduction of Anastomotic Leakage after resection for rectal cancer: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial

Remote Ischemic Preconditioning (RIPC) versus sham-control for reduction of Anastomotic Leakage after resection for rectal cancer: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial - RIPAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00018942

Enrollment

Registered

2019-10-31

Start date

2019-12-10

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 K91.83

Interventions

Group 1: Experimental Arm/ Study Intervention: In RIPC, a blood pressure cuff is placed around an arm immediately prior to surgery (after induction of anesthesia and before/ during incision/dissection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Persons meeting the following criteria may be included in the study: • Planned elective continence-preserving rectal resection for rectal cancer • Signed informed consent • Age =18 years

Exclusion criteria

Exclusion criteria: Persons meeting any of the following criteria cannot be included in the study: • Patients not able to give informed consent • Patients presenting with the following contraindications to the study intervention (RIPC): arterial occlusive disease (AOD), infections or wounds on the upper extremity, poorly controlled diabetes mellitus, or deep vein thrombosis of the upper extremity

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the anastomotic leakage rate within 30 days after surgery. Anastomotic leakage is defined and classified according to the recommendation of the International Study Group of Rectal Cancer (Rahbari NN et al. (2010) Definition and Grading of Anastomotic Leakage: a proposal by the International Study Group of Rectal Cancer Surgery 147 (3): 339-351). In patients with suspicious clinical symptoms (pain, fever, increased infection parameters, tachycardia / hypotension), anastomotic leakage is confirmed / excluded by endoscopic or radiographic (computed tomography with rectal contrast enema) examinations. This corresponds to the clinical standard. All asymptomatic patients will undergo an endoscopic control of anastomotic healing on postoperative day (POD) 5 (+/- 1 day) to assess the primary endpoint.	—

Measure

Time frame

The primary endpoint is the anastomotic leakage rate within 30 days after surgery. Anastomotic leakage is defined and classified according to the recommendation of the International Study Group of Rectal Cancer (Rahbari NN et al. (2010) Definition and Grading of Anastomotic Leakage: a proposal by the International Study Group of Rectal Cancer Surgery 147 (3): 339-351). In patients with suspicious clinical symptoms (pain, fever, increased infection parameters, tachycardia / hypotension), anastomotic leakage is confirmed / excluded by endoscopic or radiographic (computed tomography with rectal contrast enema) examinations. This corresponds to the clinical standard. All asymptomatic patients will undergo an endoscopic control of anastomotic healing on postoperative day (POD) 5 (+/- 1 day) to assess the primary endpoint.

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Secondary

Measure	Time frame
Secondary endpoints are perioperative morbidity and mortality (Clavien-Dindo classification), conduit necrosis, chyle leak, recurrent nerve palsy (defined by the ECCG), need for/duration of re-interventions (endoluminal vacuum therapy, interventional drainage, re-operation), hospital/ICU stay and readmissions. Effects of RIPC on biomarkers of ischemia-reperfusion injury (serotonin, VEGF) and necrotic cell death (Hmgb1) will be measured in plasma before RIPC (t0), immediately after RIPC (t1), and at 3 hours after RIPC (t2) using ELISA.	—

Measure

Time frame

Secondary endpoints are perioperative morbidity and mortality (Clavien-Dindo classification), conduit necrosis, chyle leak, recurrent nerve palsy (defined by the ECCG), need for/duration of re-interventions (endoluminal vacuum therapy, interventional drainage, re-operation), hospital/ICU stay and readmissions. Effects of RIPC on biomarkers of ischemia-reperfusion injury (serotonin, VEGF) and necrotic cell death (Hmgb1) will be measured in plasma before RIPC (t0), immediately after RIPC (t1), and at 3 hours after RIPC (t2) using ELISA.

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Countries

Germany

Contacts

Public ContactJulia Hardt

Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik

julia.hardt@umm.de0621-383-2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026