An interventional study of Robotic vs laparoscopic surgery in Recovery Outcomes, sponsored by Hospital Central do Funchal. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Hospital Central do Funchal · Not applicable, Interventional, and Other
Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire.
This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
Background and rationale Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire.
This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
Objectives Primary objective: To compare patient-reported quality of recovery (QoR-15 total score) at 24 hours postoperatively between patients undergoing surgeon-allocated robotic vs laparoscopic colorectal surgery following ERAS protocol.
Secondary objectives:
Inclusion / exclusion criteria Inclusion: Age ≥ 18 years, scheduled for elective colorectal resection (laparoscopic or robot-assisted), ASA I-III, able to consent and complete QoR-15, included in ERAS pathway.
Exclusion: Emergency surgery, concomitant major non-colorectal procedure, severe cognitive impairment, refusal/inability to consent.
Sample size and power According to the previous literature, the standard deviation (SD) of the total QoR-15 score in the Portuguese population is 14 [7]. An 8-point difference in the QoR-15 score represents the MCID that defines if the quality of recovery was improved (a positive 8-point difference) or worsened (a negative 8-point difference) [8, 9]. A minimum of 49 patients in each group were obtained (3 = 0.05 and 4 = 0.20). Considering 10% possible losses during the study (dropouts), the final sample constituted 110 patients.
Parameters: alpha=0.05, 80% power, MCID 6-10 points, SD 12-22. Formula: n per group = 2 × (Zα/2 + Zβ)\^2 × σ\^2 / δ\^2. Example: For MCID=8, SD=14 → \~49 per group (98 total). Considering \~ 10% added for missing data, final sample is 110 (55 per group). Sample size table attached in appendix.
Hospital Central do Funchal is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Robotic vs laparoscopic surgery
Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is determined by the operating surgeon (non-randomised). The anaesthetist will enrol and collect preop, intraop and postop data. Statistical methods will adjust for confounding (propensity-score methods, multivariable regression, clustering by surgeon).
Primary outcome: Quality of Recovery-15 (QoR-15) total score at 24 hours after surgery (±4 h window).
The total score ranges from 0 (very poor recovery) to 150 (excellent quality of recovery).
Time frame: January 2026 - May 2027
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for May 2027, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Central do Funchal