Clinical trial NCT03334383: Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery
Official title: Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Carcinoma
Rectum Carcinoma
Keywords: Laparoscopic colorectal surgery
Retractor sponge
Trendelenburg position
Postoperative complications
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.

Detailed description: Objective: We study the efficacy of the retractor sponge in laparoscopic colorectal surgery to reduce hospital stay in patients operated for a malignancy. Secondary objectives are duration of surgery, blood-loss, use of diuretics as volume therapy (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative complications.

Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.

Study population: Patients with colorectal cancer who undergo laparoscopic surgery, and who have given informed consent to be offered experimental interventions within the PICNIC project. 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 length of hospital stay. Secondary endpoints are duration of surgery, blood-loss, use of diuretics (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative surgical, pulmonary and cardiac 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 PICNIC cohort, we will identify all patients who are eligible for the experimental intervention (use of the sponge) 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, besides dysfunction of the sponge, after which conversion to standard treatment (Trendelenburg position) needs to take place.

Eligibility criteria: Inclusion criteria:

* Participant in the PICNIC project (METC 12-510)
* Informed consent obtained for being offered experimental interventions within the PICNIC project
* Informed consent obtained for questionnaires on patient reported outcomes within the PICNIC project
* Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital

Exclusion Criteria:

* Planned for open colorectal surgery
* Surgery for benign colorectal diseases
* Emergency colorectal surgery
* Inadequate understanding of the Dutch language in speech and/or writing

Primary outcomes:
measure: Postoperative hospital stay (days)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Operation time
timeFrame: Up to 4 hours
measure: Blood-loss peroperative
timeFrame: During surgery time
measure: Diuretics peroperative and postoperative
timeFrame: Up to 4 weeks (during hospital stay)
measure: Postoperative hypoxemia
timeFrame: Up to 1 week
measure: Peri- and postoperative surgical complications
timeFrame: Up to 4 weeks
measure: Pulmonary complications.
timeFrame: Up to 4 weeks
measure: Cardiac complications
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Anke B Smits, MD
role: PRINCIPAL_INVESTIGATOR
References: