Laparoscopic Appendectomy by Multi-port vs Single Port.

NCT ID: NCT01720082

Last Updated: 2012-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

Brief Summary

Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.

Conditions

Acute Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single incision laparoscopic appendectomy

Acute appendicitis with surgical indication

Group Type: ACTIVE_COMPARATOR

Single incision laparoscopic appendectomy

Intervention Type: PROCEDURE

A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Multiport Laparoscopic appendectomy

Acute appendicitis with surgical indication

Group Type: ACTIVE_COMPARATOR

Multiport laparoscopic appendectomy

Intervention Type: PROCEDURE

Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Interventions

Single incision laparoscopic appendectomy

A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Intervention Type: PROCEDURE

Multiport laparoscopic appendectomy

Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Intervention Type: PROCEDURE

Other Intervention Names

SILA; LA

Eligibility Criteria

Inclusion Criteria

• age: 14-60
• American Society of Anesthesiologists (ASA) score: I-III
• absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
• diagnosis: acute appendicitis with surgical indication

Exclusion Criteria

• Complicated appendicitis after exploration or previously diagnosed (CT)
• Psychical inability
• Pregnancy

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)

UNKNOWN

Sponsor Role: collaborator

Associazione Chirurghi Ospedalieri Italiani

OTHER

Sponsor Role: lead

Responsible Party

Nereo Vettoretto

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nereo Vettoretto, MD

Role: STUDY_CHAIR

ACOI - SICE

Ferdinando Agresta, MD

Role: STUDY_CHAIR

ACOI - SICE

Luigi Boni, MD, FACS

Role: STUDY_CHAIR

SICE

Locations

M.Mellini Hospital

Chiari, BS, Italy

Countries

Italy

Central Contacts

Nereo Vettoretto, MD

Role: CONTACT

Phone: 00393492237383

Email: nereovet@gmail.com

Other Identifiers

ACOI - SICE

Identifier Type: -

Identifier Source: org_study_id