Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain

NCT01675466 | Terminated Phase 4

• 1 other identifier: ABC123
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with acute abdominal pain comprise a significant proportion of attendances at emergency departments. These patients account for about a third of general surgical admissions in a typical day. In some cases, the diagnosis is clear from baseline investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains unclear but there are signs that necessitate urgent surgery (for example in cases of appendicitis). A final group exists where no clear explanation for the pain is found and where there are insufficient clinical signs to warrant surgery. These patients are said to have "non specific abdominal pain" (NSAP) and present a management dilemma. Traditionally such patients are managed with a strategy of active observation. Patients are examined at regular intervals and may undergo imaging. In some cases, symptoms and signs progress and surgery is needed while in other cases resolution may occur or a diagnosis may be reached non-operatively allowing focused medical treatment. Recently, two alternative strategies have emerged. Early cross-sectional imaging using CT scanning may identify conditions whilst being non-invasive. This would allow diagnosis and treatment would follow. The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of concomitant therapy, but is invasive. The study hypothesis is that in patients with acute non-specific abdominal pain active management with laparoscopy on admission will reduce hospital stay and costs when compared to traditional active observation, without increasing complications.

Conditions

Non-specific Abdominal Pain

Keywords

non-specific abdominal pain; undifferentiated abdominal pain; appendicitis; appendicectomy; appendectomy; surgery; laparoscopy; antibiotics; randomised controlled trial; randomized controlled trial; controlled clinical trial; randomised; placebo

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.

  the length of inpatient stay

Secondary Outcomes (8)

• Complications within 30 days

  within 30 days following randomisation

• further radiological investigations during inpatient stay

  during inpatient stay

• readmission to hospital with abdominal pain

  from randomisation to 6 months

• SF36 score at 4 weeks

  from randomisation to4 weeks

• SF36 score at 6 months

  6 months following randomisation

Study Arms (2)

early laparoscopy

ACTIVE COMPARATOR

early laparoscopy, aiming to achieve this within 12 hours

Procedure: early laparoscopy; Procedure: General anaesthesia; Device: Laparoscopic instruments

active observation

PLACEBO COMPARATOR

standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary

Interventions

early laparoscopy PROCEDURE

Laparoscopy under performed by the surgeon on duty or his/her deputy. The aim is to achieve this within 12 hours of randomisation. This will be performed under general anaesthetic and involve the necessary drugs. The procedure will require laparoscopy instruments. There will be a umbilical port which will be 10mm in size and one 5mm port below this. If pathology is found, a further port will be needed to perform treatment.

early laparoscopy

General anaesthesia PROCEDURE

early laparoscopy

Laparoscopic instruments DEVICE

Also known as: Laparoscopic camera, Maryland laparoscopic grasper, Endoclinch laparoscopic grasper, Endobag, Laparoscopic suction

early laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18
• admission with abdominal pain for up to one week prior to admission deemed to be non-specific pain by senior surgical team member
• patient willing to give full informed consent for participation

You may not qualify if:

• patients less than 18 years of age
• pain of greater than 7 days duration
• admission with abdominal pain in previous 6 months
• history of inflammatory bowel disease
• previous history of appendicectomy
• previous surgery rendering laparoscopy unsafe eg. multiple laparotomies
• history of intra-abdominal transplant including retroperitoneal renal allografting
• clinical picture necessitating immediate surgical procedure
• cases involving trauma
• patients who are unable or unwilling to give full informed consent

Sponsors & Collaborators

• Mid Western Regional Hospital, Ireland: lead

Study Sites (1)

University Hospital Limerick

Limerick, Limerick, Ireland

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Donagh A Healy, MB

  PRINCIPAL INVESTIGATOR

• Stewart R Walsh, MB MCh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

IE (1)