Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery

NCT ID: NCT03334383

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-10-31

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.

Conditions

Colon Carcinoma; Rectum Carcinoma

Keywords

Laparoscopic colorectal surgery; Retractor sponge; Trendelenburg position; Postoperative complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sponge group

Patients offered surgery with the retractor sponge

Group Type: EXPERIMENTAL

Sponge

Intervention Type: DEVICE

Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.

Control group

Patients receiving standard care: surgery in Trendelenburg position

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sponge

Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.

Intervention Type: DEVICE

Other Intervention Names

Endoractor, Kawamoto corporation (Osaka, Japan)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

dr. A.B. Smits

Dr. A.M. Smits

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anke B Smits, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Anke B Smits, MD

Role: CONTACT

Phone: 0031883201919

Email: absmits@antoniusziekenhuis.nl

Alice M Couwenberg, BSc

Role: CONTACT

Phone: 0031640904560

Email: alice.couwenberg@gmail.com

Facility Contacts

Anke B Smits, MD

Role: primary

Alice M Couwenberg, BSc

Role: backup

Other Identifiers

49877

Identifier Type: REGISTRY

Identifier Source: secondary_id

49877

Identifier Type: -

Identifier Source: org_study_id