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To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in Trendelenburg position. This position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as alternative for the Trendelenburg position during laparoscopic surgery.
Objective: To study the impact of use of an intraoperative retractor sponge on duration of hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.
Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design (clinicaltrials.gov NCT02070146).
Study population: Patients with colorectal cancer who undergo laparoscopic sigmoid of rectal resection, and who have given informed consent to be offered experimental interventions within the prospective cohort. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.
Intervention: Intraoperative use of the retractor sponge versus usual care, i.e. the Trendelenburg position.
Main study parameters/endpoints: The primary endpoint is hospital stay. Secondary objectives are operation time, blood-loss, fluid balance, body temperature, oxygen therapy and postoperative complications.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be conducted according to the cohort multiple Randomized Controlled Trial (cmRCT) design. Within the PLCRC cohort, we will identify all patients who are eligible for the experimental intervention and who have given informed consent to be invited for future experimental interventions. From this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. Eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in Trendelenburg position. We do not expect adverse events in patients in the intervention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sponge-assisted surgery group | Experimental | Patients offered surgery with use of the retractor sponge |
|
| Control group | No Intervention | Patients receiving standard care, i.e. surgery in Trendelenburg position |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoractor® | Device | Endoscopic sponge for retraction of small intestine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Discharge is based on a checklist | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time (minutes) | Intraoperative | |
| Blood-loss (ml) | Intraoperative | |
| Fluid balance (L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anke B Smits, MD PhD | Contact | 0031883201919 | a.smits@antoniusziekenhuis.nl | |
| Helena M Verkooijen, MD PhD | Contact | 0031887559575 | h.m.verkooijen@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Anke B Smits, MD PhD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Recruiting | Nieuwegein | Utrecht | 3430 EM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35909251 | Derived | Fahim M, Couwenberg A, Verweij ME, Dijksman LM, Verkooijen HM, Smits AB. SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial. Br J Surg. 2022 Oct 14;109(11):1081-1086. doi: 10.1093/bjs/znac249. | |
| 26964861 | Derived | Couwenberg AM, Burbach MJ, Smits AB, Van Vulpen M, Van Grevenstein WM, Noordzij PG, Verkooijen HM. The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):132. doi: 10.1186/s13063-016-1256-x. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Intraoperative |
| Postoperative body temperature | Baseline |
| Postoperative oxygen therapy | Number of participants in need for oxygen therapy leaving the recovery room. | Baseline |
| Postoperative complications | Including cardiac, pulmonary, surgical, infectious and thrombovascular events | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |