Clinical trial · Interventional
Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery
Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery: A Double Blinded Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to investigate the influence of low intraabdominal pressure (compared to standard intraabdominal pressure) during robot-assisted colorectal cancer surgery on patients wellbeing after surgery. Patients included are diagnosed with colon- or rectal cancer, and scheduled for curatively intended surgery. The main question the trial aims to answer is: Does low intraabdominal pressure during robot-assisted colorectal cancer surgery increase the patients wellbeing after surgery? Researchers will compare low intraabdominal pressure (8 mmHg) to standard intraabdominal pressure (12 mmHg) to see if there is a difference in quality of recovery scores, pain scores and analgetic consumption. Participants will be asked to fill out the Quality of Recovery 15 (QoR15) questionnaire 8 hours, 24 hours and 48 hours after surgery. Furthermore, patients will be asked to evaluate abdominal pain and shoulder tip pain using the visual analog scale (VAS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low intraabdominal pressure (8 mmHg) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low pressure (8 mmHg)
- description
- Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with low intraabdominal pressure (8 mmHg)
- interventionNames
- Other: Low intraabdominal pressure (8 mmHg)
- type
- NO_INTERVENTION
- label
- Standard pressure (12 mmHg)
- description
- Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with standard intraabdominal pressure (12 mmHg)
Primary outcomes (1)
- measure
- Quality of recovery 15 (QoR15) questionnaire 8 hours after surgery
- timeFrame
- From end of surgery until 8 hours later
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years * a diagnosis of colorectal cancer * scheduled for curative intended robot-assisted resection Exclusion Criteria: * BMI above 35 * inability to fulfill QoR15 questionnaire * construction of a stoma either proactive or permanent * metastatic cancer disease * recieving neoadjuvant treatment * previous multiple abdominal operations defined as 3 or more
References
Publications (25)
- BACKGROUNDDohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13. PMID 35129520
- BACKGROUNDKleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13. PMID 25867135
- BACKGROUNDKleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PMID 29397134
- BACKGROUNDNeudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi Ch, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1121-43. doi: 10.1007/s00464-001-9166-7. Epub 2001 May 20. PMID 12015619
- BACKGROUNDHamid M, Mostafa OES, Mohamedahmed AYY, Zaman S, Kumar P, Waterland P, Akingboye A. Comparison of low versus high (standard) intraabdominal pressure during laparoscopic colorectal surgery: systematic review and meta-analysis. Int J Colorectal Dis. 2024 Jul 10;39(1):104. doi: 10.1007/s00384-024-04679-8. PMID 38985344
- BACKGROUNDAlbers KI, Polat F, Helder L, Panhuizen IF, Snoeck MMJ, Polle SBW, de Vries H, Dias EM, Slooter GD, de Boer HD, Diaz-Cambronero O, Mazzinari G, Scheffer GJ, Keijzer C, Warle MC; RECOVER Study Collaborators. Quality of Recovery and Innate Immune Homeostasis in Patients Undergoing Low-pressure Versus Standard-pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery (RECOVER): A Randomized Controlled Trial. Ann Surg. 2022 Dec 1;276(6):e664-e673. doi: 10.1097/SLA.0000000000005491. Epub 2022 Jul 13.