ClinicalTrials.gg
Status unknownNCT03267082Updated Aug 30, 2017

Evaluation the Role of Laparoscopic Management of Perforated Appendicitis

An interventional study of Laparoscopic management of perforated appendicitis in Perforated Appendicitis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.

Read the detailed description

The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.

this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.

02

Conditions studied

  • Perforated Appendicitis

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03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 30 is below the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of acute perforated appendicitis
  • fit for laparoscopy and general anesthesia.
  • written .
  • short term outcome data and agree to provide contact information.

Exclusion criteria

Exclusion Criteria:

  • high risk for general anesthesia.
  • Appendicular abscess and appendicular mass .
  • ongoing infections including chest infections .
  • Children and pregnant females .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Evaluation the role of Laparoscopic management of perforated a

    Other: Laparoscopic management of perforated appendicitis

Interventions

  • OtherLaparoscopic management of perforated appendicitis

    1. Insertion of Ports 2. Exposure of the Appendix 3. peritoneal toilet and aspiration of pus after abdominal exposure 4. Isolation of Mesoappendicular Artery 5. Clipping and Dividing of the Artery 6. Application of 3 x Endoloops 7. Division of the Appendix 8. Retrieval of the Appendix in an Endobag

06

What researchers measure

Primary outcomes

  1. early recovery

    recovery within 2 days

    Time frame: 2 day

Secondary outcomes

  1. wound cosmetic appearance

    no scare of incision post laporscopic mangement

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466. PubMed 6221925 ↗
  • Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010. PubMed 8624197 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2017; primary completion for Mar 2019, 18 months later.

Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 18 months is close to that.

Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2017
First posted
Aug 30, 2017
StartEst.
Sep 15, 2017
Primary completionEst.
Mar 15, 2019
CompletionEst.
Mar 15, 2019
Last update
Aug 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03267082
Lead sponsor
Assiut University
Responsible party
samir hosny mahmoud mohamed (general surgery, Assiut University) — Principal investigator
First posted
Aug 30, 2017
Start date
Sep 15, 2017 (estimated)
Primary completion
Mar 15, 2019 (estimated)
Completion
Mar 15, 2019 (estimated)
Last update
Aug 30, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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