Perforated AppendicitisNCT00677989
Study on Laparoscopic Operation for Perforated Appendicitis
An observational study of Perforated Appendicitis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Laparoscopic appendectomy and Open appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with perforated appendicitis treated at the Far-Eastern Memorial Hospital, Taipei,Taiwan
Who may be able to join
- All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant.
- The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation.
- Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent.
Who cannot join
- Age less than 12 years
- older than 80 years
- perforated appendicitis was not revealed by pathologic investigation
- diverticulitis being diagnosed during surgery
- pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation
- the patient declining to enroll in this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Surgical Department, Far-Eastern Memorial Hospital
Taipei, 220
About this study
Official title: The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis
The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.
Read the detailed description
The role of laparoscopic appendectomy (LA) for perforated appendicitis is under investigation. According to the results of a previous retrospective study conducted in Far-Eastern Memorial Hospital comparing the clinical outcomes between perforated appendicitis patients treated by laparoscopic and open approach showed favored clinical outcomes for LA. Same as a few studies indicated that laparoscopic appendectomy is a safe and effective procedure for treating patients with perforated appendicitis in terms of hospital stay and wound complications. One the other hand, some authors still concern about the adverse effects of laparoscopy for ruptured appendicitis patients in terms of longer operation time and increased rates of postoperative abscess formation. We hypothesize that prolonged CO2 pneumoperitoneum will produce transient mesenteric ischemic and reperfusion injury when CO2 disinflation, and the free radicals and oxidative proteins provoked by reperfusion injury are responsible for the adverse reaction of LA. The objective of this prospective non-randomized controlled study is to examine the safety and efficacy of laparoscopic appendectomy and compare its outcome with that of the conventional approach for perforated appendicitis patients, with special emphasis on postoperative complication and oxidative stress resulted from pneumoperitoneum..
- Conditions
- Perforated Appendicitis
- Being tested
- Laparoscopic appendectomy, Open appendectomy
- Keywords
- perforated appendicitis, laparoscopic appendectomy, open appendectomy, cytokines, free radicals, oxidized proteins
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
laparoscopic appendectomy:did appendectomy by laparoscopic manipulation
Open appendectomyProcedure or surgery
open appendectomy: did appendectomy by laparotomy
| Study group | Role | What they receive |
|---|---|---|
| LA | LA group: patients with perforated appendicitis treated by laparoscopic operation intentionally Receives: Procedure: Laparoscopic appendectomy | |
| OA | OA group:patients with perforated appendicitis treated by open approach Receives: Procedure: Open appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
paraoperative outcomes
Measured: till patients are discharged
Secondary outcomes (1)
levels of paraoperative serum cytokines, free radicals, and oxidized proteins.
Measured: since preoperative preparation till 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Heng-Fu Lin, MD, Principal investigator, Traumatology division, Surgical department, Far-Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677989
- Sponsor's protocol ID
- FEMH No. 96044
- Status last verified
- Jan 2009
- First submitted
- 13 May 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
PubMed 6221925Chung RS, Rowland DY, Li P, Diaz J. A meta-analysis of randomized controlled trials of laparoscopic versus conventional appendectomy. Am J Surg. 1999 Mar;177(3):250-6. doi: 10.1016/s0002-9610(99)00017-3.
PubMed 10219865Garbutt JM, Soper NJ, Shannon WD, Botero A, Littenberg B. Meta-analysis of randomized controlled trials comparing laparoscopic and open appendectomy. Surg Laparosc Endosc. 1999 Jan;9(1):17-26.
PubMed 9950122Golub R, Siddiqui F, Pohl D. Laparoscopic versus open appendectomy: a metaanalysis. J Am Coll Surg. 1998 May;186(5):545-53. doi: 10.1016/s1072-7515(98)00080-5.
PubMed 9583695Sauerland S, Lefering R, Holthausen U, Neugebauer EA. Laparoscopic vs conventional appendectomy--a meta-analysis of randomised controlled trials. Langenbecks Arch Surg. 1998 Aug;383(3-4):289-95. doi: 10.1007/s004230050135.
PubMed 9776459Temple LK, Litwin DE, McLeod RS. A meta-analysis of laparoscopic versus open appendectomy in patients suspected of having acute appendicitis. Can J Surg. 1999 Oct;42(5):377-83.
PubMed 10526524Frazee 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 8624197Klingler A, Henle KP, Beller S, Rechner J, Zerz A, Wetscher GJ, Szinicz G. Laparoscopic appendectomy does not change the incidence of postoperative infectious complications. Am J Surg. 1998 Mar;175(3):232-5. doi: 10.1016/s0002-9610(97)00286-9.
PubMed 9560127So JB, Chiong EC, Chiong E, Cheah WK, Lomanto D, Goh P, Kum CK. Laparoscopic appendectomy for perforated appendicitis. World J Surg. 2002 Dec;26(12):1485-8. doi: 10.1007/s00268-002-6457-7. Epub 2002 Sep 26.
PubMed 12297916Lin HF, Wu JM, Tseng LM, Chen KH, Huang SH, Lai IR. Laparoscopic versus open appendectomy for perforated appendicitis. J Gastrointest Surg. 2006 Jun;10(6):906-10. doi: 10.1016/j.gassur.2005.12.012.
PubMed 16769550Martin LC, Puente I, Sosa JL, Bassin A, Breslaw R, McKenney MG, Ginzburg E, Sleeman D. Open versus laparoscopic appendectomy. A prospective randomized comparison. Ann Surg. 1995 Sep;222(3):256-61; discussion 261-2. doi: 10.1097/00000658-199509000-00004.
PubMed 7677456Yao CC, Lin CS, Yang CC. Laparoscopic appendectomy for ruptured appendicitis. Surg Laparosc Endosc Percutan Tech. 1999 Aug;9(4):271-3.
PubMed 10871175Joris J, Cigarini I, Legrand M, Jacquet N, De Groote D, Franchimont P, Lamy M. Metabolic and respiratory changes after cholecystectomy performed via laparotomy or laparoscopy. Br J Anaesth. 1992 Oct;69(4):341-5. doi: 10.1093/bja/69.4.341.
PubMed 1419439Cho JM, LaPorta AJ, Clark JR, Schofield MJ, Hammond SL, Mallory PL 2nd. Response of serum cytokines in patients undergoing laparoscopic cholecystectomy. Surg Endosc. 1994 Dec;8(12):1380-3; discussion 1383-4. doi: 10.1007/BF00187340.
PubMed 7878501
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT00677989
- Acronym / sponsor ID
- FEMH No. 96044
- Conditions
- Perforated Appendicitis
- Keywords
- perforated appendicitis, laparoscopic appendectomy, open appendectomy, cytokines, free radicals, oxidized proteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.
Detailed description
The role of laparoscopic appendectomy (LA) for perforated appendicitis is under investigation. According to the results of a previous retrospective study conducted in Far-Eastern Memorial Hospital comparing the clinical outcomes between perforated appendicitis patients treated by laparoscopic and open approach showed favored clinical outcomes for LA. Same as a few studies indicated that laparoscopic appendectomy is a safe and effective procedure for treating patients with perforated appendicitis in terms of hospital stay and wound complications. One the other hand, some authors still concern about the adverse effects of laparoscopy for ruptured appendicitis patients in terms of longer operation time and increased rates of postoperative abscess formation. We hypothesize that prolonged CO2 pneumoperitoneum will produce transient mesenteric ischemic and reperfusion injury when CO2 disinflation, and the free radicals and oxidative proteins provoked by reperfusion injury are responsible for the adverse reaction of LA. The objective of this prospective non-randomized controlled study is to examine the safety and efficacy of laparoscopic appendectomy and compare its outcome with that of the conventional approach for perforated appendicitis patients, with special emphasis on postoperative complication and oxidative stress resulted from pneumoperitoneum..
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA | – | Procedure: Laparoscopic appendectomyLA group: patients with perforated appendicitis treated by laparoscopic operation intentionally |
| OA | – | Procedure: Open appendectomyOA group:patients with perforated appendicitis treated by open approach |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with perforated appendicitis treated at the Far-Eastern Memorial Hospital, Taipei,Taiwan
Key inclusion criteria (3 listed)
- All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant.
- The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation.
- Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent.
Key exclusion criteria (6 listed)
- Age less than 12 years
- older than 80 years
- perforated appendicitis was not revealed by pathologic investigation
- diverticulitis being diagnosed during surgery
- pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomylaparoscopic appendectomy:did appendectomy by laparoscopic manipulation | Procedure or surgery | LA |
| Open appendectomyopen appendectomy: did appendectomy by laparotomy | Procedure or surgery | OA |
Primary outcome
paraoperative outcomes
Time frame: till patients are discharged
1 secondary outcome
levels of paraoperative serum cytokines, free radicals, and oxidized proteins.
Time frame: since preoperative preparation till 48 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
- Background: PubMed 6221925Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
- Background: PubMed 10219865Chung RS, Rowland DY, Li P, Diaz J. A meta-analysis of randomized controlled trials of laparoscopic versus conventional appendectomy. Am J Surg. 1999 Mar;177(3):250-6. doi: 10.1016/s0002-9610(99)00017-3.
- Background: PubMed 9950122Garbutt JM, Soper NJ, Shannon WD, Botero A, Littenberg B. Meta-analysis of randomized controlled trials comparing laparoscopic and open appendectomy. Surg Laparosc Endosc. 1999 Jan;9(1):17-26.
- Background: PubMed 9583695Golub R, Siddiqui F, Pohl D. Laparoscopic versus open appendectomy: a metaanalysis. J Am Coll Surg. 1998 May;186(5):545-53. doi: 10.1016/s1072-7515(98)00080-5.
- Background: PubMed 9776459Sauerland S, Lefering R, Holthausen U, Neugebauer EA. Laparoscopic vs conventional appendectomy--a meta-analysis of randomised controlled trials. Langenbecks Arch Surg. 1998 Aug;383(3-4):289-95. doi: 10.1007/s004230050135.
- Background: PubMed 10526524Temple LK, Litwin DE, McLeod RS. A meta-analysis of laparoscopic versus open appendectomy in patients suspected of having acute appendicitis. Can J Surg. 1999 Oct;42(5):377-83.
- Background: PubMed 8624197Frazee 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.
- Background: PubMed 9560127Klingler A, Henle KP, Beller S, Rechner J, Zerz A, Wetscher GJ, Szinicz G. Laparoscopic appendectomy does not change the incidence of postoperative infectious complications. Am J Surg. 1998 Mar;175(3):232-5. doi: 10.1016/s0002-9610(97)00286-9.
- Background: PubMed 12297916So JB, Chiong EC, Chiong E, Cheah WK, Lomanto D, Goh P, Kum CK. Laparoscopic appendectomy for perforated appendicitis. World J Surg. 2002 Dec;26(12):1485-8. doi: 10.1007/s00268-002-6457-7. Epub 2002 Sep 26.
- Background: PubMed 16769550Lin HF, Wu JM, Tseng LM, Chen KH, Huang SH, Lai IR. Laparoscopic versus open appendectomy for perforated appendicitis. J Gastrointest Surg. 2006 Jun;10(6):906-10. doi: 10.1016/j.gassur.2005.12.012.
- Background: PubMed 7677456Martin LC, Puente I, Sosa JL, Bassin A, Breslaw R, McKenney MG, Ginzburg E, Sleeman D. Open versus laparoscopic appendectomy. A prospective randomized comparison. Ann Surg. 1995 Sep;222(3):256-61; discussion 261-2. doi: 10.1097/00000658-199509000-00004.
- Background: PubMed 10871175Yao CC, Lin CS, Yang CC. Laparoscopic appendectomy for ruptured appendicitis. Surg Laparosc Endosc Percutan Tech. 1999 Aug;9(4):271-3.
Related trials for Perforated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heng-Fu Lin, MD principal investigator
Traumatology division, Surgical department, Far-Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforated Appendicitis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heng-Fu Lin, MD (886-2-8966-7000 ext. 1612, hengfu57@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
paraoperative outcomes (time frame: till patients are discharged). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677989, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.