NCT02688244

Brief Summary

This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

December 1, 2015

Last Update Submit

February 17, 2016

Conditions

AppendicitisAbdominal AbscessAcute DiseaseCecal DiseasesInfection

Keywords

complicated appendicitislaparoscopic appendectomyirrigationsuctionabdominal abscess

Outcome Measures

Primary Outcomes (3)

  • Incidence of post-operative abscess

    Number of post-operative abscesses in each arm

    1 month

  • Location of post-operative abscess

    Number of abscesses in every quadrant of the abdomen

    One month

  • Treatment of post-operative abscess

    Number of post-operative abscesses treated with a radiological drain

    One month

Secondary Outcomes (4)

  • Operating time

    1 day

  • Hospital stay (Time until discharge)

    2 weeks

  • Postoperative pain (Visual analogic scale)

    6 days

  • Postoperatory fever

    6 days

Study Arms (2)

Irrigation

ACTIVE COMPARATOR

Irrigation of the area with at least 300ml normal saline using the power suction/irrigator

Procedure: Irrigation

No irrigation

ACTIVE COMPARATOR

Only suction with the power suction/irrigator without saline attached

Procedure: No irrigation

Interventions

IrrigationPROCEDURE

Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator

Also known as: Washout
Irrigation
No irrigationPROCEDURE

Suction only, using suction device

Also known as: Suction
No irrigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with complicated acute appendiccitis
  • Laparoscopic approach

You may not qualify if:

  • Open approach
  • Medical or psychiatric condition of the patient that compromises the informed consent authorisation
  • Non complicated acute appendicitis
  • Underage patients (\<18)
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de La Arrixaca

Murcia, Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

AppendicitisAbdominal AbscessAcute DiseaseCecal DiseasesInfections

Interventions

Therapeutic IrrigationWASH protein, DrosophilaSuction

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesAbscessSuppurationDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesDrainageSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 1, 2015

First Posted

February 23, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

ES(1)